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Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT01260935
First received: November 30, 2010
Last updated: January 16, 2012
Last verified: January 2012

November 30, 2010
January 16, 2012
November 2002
November 2010   (final data collection date for primary outcome measure)
Determine whether Laparoscopic Hill repair is as effective as Nissen fundoplication for the treatment of gastroesophageal reflux disease (GERD). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Comparison of these two surgical procedures will be based on pre- and post-surgery quality of life questionnaires, manometry (test that measures muscle pressures in the lower esophagus), pH testing, operative time, early complication rates, and length of hospital stay.
Same as current
Complete list of historical versions of study NCT01260935 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Comparison of Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures
A Prospective Randomized Single-Blinded Multi-Institutional Study Comparing the Laparoscopic Hill and Laparoscopic Nissen Anti-Reflux Procedures

The purpose of this study is to compare the effects (good and bad) of the Laparoscopic Hill anti-reflux procedure with the Laparoscopic Nissen anti-reflux surgical procedure to see whether one is better than the other.

The design is a two-armed prospective single-blinded comparison between the two procedures, performed and randomized independently at the Swedish Medical Center Cancer Institute in Seattle, WA, and at Legacy Health Systems in Portland, OR, in adult patients with uncomplicated gastroesophageal reflux failing medical management. A standardized operative technique for each procedures will be utilized at both institutions, and will include intraoperative manometrics and intraoperative photographic documentation of the gastroesophageal valve, as well as placement of clips at the GE junction to accurately identify its location post-operatively. To eliminate "expertise" bias, the investigator from each institution will participate in up to 50 of the first of each of the two procedures.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
  • Gastroesophageal Reflux
  • Esophageal Reflux
  • Gastroesophageal Reflux Disease
  • GERD
  • Procedure: Laparoscopic Hill Repair
    With the Hill repair, stitches are placed right where the esophagus and stomach meet and attached to muscle tissue that is fixed to the spine.
  • Procedure: Laparoscopic Nissen Repair
    With the Nissen repair, the upper part of the stomach is wrapped around the esophagus, with some anchoring of the wrap at several locations.
  • Active Comparator: Arm A
    Laparoscopic Hill
    Intervention: Procedure: Laparoscopic Hill Repair
  • Active Comparator: Arm B
    Laparoscopic Nissen
    Intervention: Procedure: Laparoscopic Nissen Repair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
121
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • abnormal levels of gastroesophageal reflux documented by pH monitoring who are failing medical management or are requiring maximal medical therapy for control
  • > 18 years of age and < 75 years of age

Exclusion Criteria:

  • hiatal hernias measuring > 7 cm
  • esophageal body amplitude < 30 or in two or more segments
  • < 40% propagated peristaltic waves
  • GE junction > 5 cm above the esophageal hiatus
  • dense fibrotic esophageal strictures which do not markedly improve with pre-operative medical therapy
  • body mass index > 40
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01260935
IR 3722
No
Swedish Medical Center
Swedish Medical Center
Not Provided
Principal Investigator: Ralph Aye, MD Swedish Medical Center Cancer Institute
Swedish Medical Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP